Clinical Trial: A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-D

Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.

Detailed Summary:

Several treatments are available for the treatment of acute manic and mixed episodes associated with bipolar disorder. Some of these treatments although used for many years, are associated with well-known problems such as poor tolerability, significant toxicities, narrow therapeutic ranges, and drug interactions. Often, several drugs must be used in combination to achieve the best clinical effect. More recently, a group of compounds known as atypical antipsychotics, such as risperidone, have been licensed for use in this indication. Paliperidone has similar properties as risperidone and is expected to be as effective in the treatment of acute manic and mixed episodes associated with bipolar disorder. Paliperidone ER has been shown to be effective in schizophrenia and it has an improved drug delivery system with a reduced potential for drug interactions.

Study drug tablets are designed to deliver the appropriate amount of drug (3 mg or 6 mg) using a "Push-Pull" delivery system based on a patented oral osmotic pump technology (OROS) that allows the drug to be delivered at a relatively controlled rate for 24 hours. This study will test flexibly-dosed paliperidone ER (3 to 12 mg/day compared with placebo (inactive substance) or flexibly-dosed quetiapine (400 to 800 mg/day). There are 4 parts to the study: a screening and washout phase that lasts up to 7 days to determine if patients are eligible for the study and to discontinue all current medications, a double-blind (neither the patient nor the physician knows whether drug or placebo and what dosage is being taken) acute treatment phase that lasts for 3 weeks, a 9-week double-blind maintenance phase to see if the effects of paliperidone are maintained over a longer period, and a follow-up phase that lasts about 1 week after the final visit or early withdrawal from the study. During the acute treatment phase, patien
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: The primary effectiveness outcome is the change in the total YMRS score from baseline to the last assessment during the acute treatment phase. [ Time Frame: 3 weeks ]

Original Primary Outcome: The primary effectiveness outcome is the change in the total YMRS score from baseline to the last assessment during the acute treatment phase.

Current Secondary Outcome: The secondary effectiveness outcomes are the change in GAF from baseline to endpoint or the last assessment during the acute treatment phase and the change in total YMRS score from baseline to endpoint or the last assessment during the maintenance phase. [ Time Frame: 12 weeks ]

Original Secondary Outcome: The secondary effectiveness outcomes are the change in GAF from baseline to endpoint or the last assessment during the acute treatment phase and the change in total YMRS score from baseline to endpoint or the last assessment during the maintenance phase.

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: March 31, 2006
Date Started: April 2006
Date Completion:
Last Updated: June 19, 2014
Last Verified: June 2014